Bimekizumab: Study participants will receive bimekizumab at pre-specified time points.
Placebo: Study participants will receive matching placebo at pre-specified time points.
Study summary
The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared with placebo in participants with palmoplantar pustulosis (PPP).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* At least 18 years of age inclusive, at the time of signing the informed consent form (ICF)
* Have a palmoplantar pustulosis (PPP) diagnosis for at least 24 weeks prior to the Screening Visit
* Have PPPASI ≥12 at the Screening Visit and Baseline Visit
* Have PPP-IGA ≥3 at the Screening Visit and Baseline Visit
* Have pustules on the palms of the hands and/or soles of the feet at the Screening Visit and Baseline Visit, defined as pustule severity ≥2 and having more than 5 active pustules
* Participant must be a candidate for systemic therapy or phototherapy
Exclusion Criteria:
* Has PPP symptoms which improve significantly between the Screening Visit and Baseline Visit, defined as a reduction in the PPPASI score
* Has the following: palmoplantar PSO (plaque PSO on palms/soles), guttate PSO, erythrodermic PSO (EP), generalized pustular PSO (GPP), Acrodermatitis continua of Hallopeau (ACH), atopic dermatitis, dyshidrotic eczema or chronic hand eczema.
* Has drug-induced PSO (eg, first onset or current exacerbation due to beta blockers, calcium channel inhibitors, lithium, or tumor necrosis factor \[TNF\] inhibitor) or drug-induced pustular PSO (eg, acute generalized exanthematous pustulosis, acute localized exanthematous pustulosis)
* Has cutaneous lesions that may interfere with the evaluation of the affected area and/or evaluation of the severity of PPP
* Is taking or has taken prohibited or restricted medications without meeting the mandatory discontinuation or stability period relative to the Baseline Visit
* Is taking or has ever taken an interleukin (IL)-17A/IL-17F inhibitor, including bimekizumab, or has participated in a bimekizumab investigational study
Primary outcome measure(s)
Palmoplantar pustulosis-Investigator Global Assessment 0/1 (PPP-IGA 0/1) response at Week 16 — At Week 16 PPP-IGA is an overall assessment by a physician regarding condition of skin lesions on the palms and the soles in PPP. The Investigator will assess the overall severity of PPP using the following 5-point scale: 0 = Clear; 1 = Almost clear; 2 = Mild ; 3 = Moderate; 4 = Severe.
Trial sites (91)
Facility
City
Region
Status
Ppp001 50754
Birmingham
Alabama
Recruiting
Ppp001 50176
Fremont
California
Recruiting
Ppp001 50746
Miami
Florida
Recruiting
Ppp001 50757
Auburn Hills
Michigan
Recruiting
Ppp001 50745
Columbus
Ohio
Recruiting
Ppp001 50202
Fairborn
Ohio
Recruiting
Ppp001 50733
Mayfield Heights
Ohio
Recruiting
Ppp001 50744
Oklahoma City
Oklahoma
Recruiting
Ppp001 50233
Barrie
Canada
Recruiting
Ppp001 50354
Calgary
Canada
Recruiting
Ppp001 50749
Fredericton
Canada
Recruiting
Ppp001 50765
London
Canada
Recruiting
Ppp001 50740
Québec
Canada
Recruiting
Ppp001 50752
Red Deer
Canada
Recruiting
Ppp001 50750
Surrey
Canada
Recruiting
Ppp001 20357
Beijing
China
Recruiting
Ppp001 20137
Chengdu
China
Recruiting
Ppp001 20352
Chengdu
China
Recruiting
Ppp001 20350
Chongqing
China
Recruiting
Ppp001 20311
Guangzhou
China
Recruiting
Ppp001 20313
Guangzhou
China
Recruiting
Ppp001 20022
Hangzhou
China
Recruiting
Ppp001 20193
Hangzhou
China
Recruiting
Ppp001 20344
Jinan
China
Recruiting
Ppp001 20355
Jinan
China
Recruiting
Ppp001 20345
Shanghai
China
Recruiting
Ppp001 20184
Shenzhen
China
Recruiting
Ppp001 20136
Tianjin
China
Recruiting
Ppp001 20356
Xi'an
China
Recruiting
Ppp001 20353
Yinchuan
China
Recruiting
Ppp001 40748
Plzen-bory
Czechia
Recruiting
Ppp001 40881
Ústí nad Labem
Czechia
Recruiting
Ppp001 40886
Hellerup
Denmark
Recruiting
Ppp001 40067
Lyon
France
Recruiting
Ppp001 40874
Nice
France
Recruiting
Ppp001 40887
Toulon
France
Recruiting
Ppp001 40875
Ahaus
Germany
Recruiting
Ppp001 40740
Bad Bentheim
Germany
Recruiting
Ppp001 40515
Berlin
Germany
Recruiting
Ppp001 40891
Bielefeld
Germany
Recruiting
+ 51 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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